Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris

NCT04277273 | Completed

• 2 other identifiers: APHP1906212019-A01640-57
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances. Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics.

Conditions

Head and Neck Neoplasm; Cleft Palate; Cleft Lip

Keywords

Head and Neck neoplasm; cleft; maxillofacial prosthesis

Outcome Measures

Primary Outcomes (1)

• Measurement of the prevalence of socio-demographic and medical characteristics of consulting patients in the consultation of Maxillofacial Prosthesis

  Characteristics such as age, gender, medical history, dental history, oral hygiene will be collected.

  During the consultation (Day 1)

Secondary Outcomes (3)

• Measurement of overall quality of life: Questionnaire WHOQOL-BREF

  During the consultation (Day 1)

• Measurement of quality of life related to oral health: Questionnaire GOHAI

  During the consultation (Day 1)

• Correlation between quality of life and clinical factors

  During the consultation (Day 1)

Study Arms (1)

Patients treated in the MaxilloFacial Prosthesis consultation

OTHER

Patients treated in the MaxilloFacial Prosthesis consultation (Dental Department, Pitié-Salpêtrière Hospital Group)

Other: Questionnaire

Interventions

Questionnaire OTHER

Questionnaires WHOQOL-BREF and GOHAI

Patients treated in the MaxilloFacial Prosthesis consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patients consulting for Maxillofacial Prosthesis management (Dental Department, Pitié-Salpêtrière Hospital Group)
• Information and collection of the patient's non-opposition to participation in the research
• Good written and oral comprehension of the French language

You may not qualify if:

• Under guardianship or curatorship
• Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Cleft Palate; Cleft Lip

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Benjamin POMES, PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: February 20, 2020
• Study Start: November 13, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: January 28, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)